Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer (EQUIP)
Pilot Trial of the Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer
i. Project Background Patients with advanced lung cancer have a high symptom burden and low quality of life. Early palliative care improves patient outcomes in newly diagnosed advanced lung cancer patients, but previously tested models are not feasible for widespread adoption. Hence, the aim of this study is to pilot a more sustainable nurse-led intervention - Enhancing Quality of life in Patients (EQUIP).
ii. Hypothesis / Aim The aims of this study are three-fold. Firstly, the investigators aim to determine the feasibility and acceptability of the EQUIP intervention itself. Secondly, the investigators aim to obtain a tentative estimate of efficacy of the EQUIP intervention. Thirdly, the investigators aim to determine the data completion rate of patient reported outcome measures in the context of the EQUIP trial.
iii. Methods Patients with newly diagnosed stage 3 or stage 4 lung cancer will be recruited and randomized to the EQUIP intervention or usual care (control) group. Patients randomized to the EQUIP intervention group will receive four face-to-face sessions with a palliative care nurse. The content of these educational sessions will equip patients with the knowledge and skills to manage the three commonest symptoms of fatigue, breathlessness and anxiety.
All participants will complete the Functional Assessment of Cancer Therapy - Lung (FACT-L), the Hospital Anxiety and Depression Scale (HADS) and the stigma subscale at four time points: baseline, 4, 8 and 12 weeks after recruitment. Measures of healthcare use will also be recorded. Additionally, participants in the intervention group will complete a feedback survey after each intervention session.
A total sample of 60 patients (30 in each arm) will be recruited.
Clinical Significance
If successful, this study will lead to a larger scale phase III trial which tests various components of the EQUIP intervention, in order to develop a sustainable and effective model for the provision of palliative care to advanced lung cancer patients.
Aperçu de l'étude
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Singapore, Singapour, 169610
- National Cancer Centre Singapore
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion criteria
- Has stage 3 or 4 lung cancer
- ECOG 0,1 or 2
- Able and willing to participate in the EQUIP programme
Exclusion criteria
- Unable to communicate in English or Mandarin
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Intervention
Participants in the EQUIP intervention group will individually receive four face-to-face sessions with a palliative care nurse. For all participants, whether in intervention or control, usual care is provided - the primary oncologist may make a referral for palliative care input if deemed appropriate. |
Patients in the EQUIP intervention group will receive four face-to-face sessions.
The focus of these sessions is to equip patients with the skills and strategies needed to cope with common symptoms experienced by lung cancer patients.
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Aucune intervention: Control
For all participants, whether in intervention or control, usual care is provided - the primary oncologist may make a referral for palliative care input if deemed appropriate.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Quality of life
Délai: 4 weeks
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Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.
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4 weeks
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Quality of life
Délai: 8 weeks
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Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.
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8 weeks
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Quality of life
Délai: 12 weeks
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Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.
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12 weeks
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Psychological distress
Délai: 4 weeks
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Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).
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4 weeks
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Psychological distress
Délai: 8 weeks
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Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).
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8 weeks
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Psychological distress
Délai: 12 weeks
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Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).
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12 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Number of participants with referral to palliative care services
Délai: 6 months
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6 months
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Number of hospital admissions
Délai: 6 months
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6 months
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Number of visits to the emergency department
Délai: 6 months
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6 months
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Autres mesures de résultats
Mesure des résultats |
Délai |
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La survie globale
Délai: 1 année
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1 année
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Number of participants who died at home
Délai: 1 year
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1 year
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Number of participants with anti-cancer therapy in the last 4 weeks of life
Délai: Last four weeks of life
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Last four weeks of life
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NCCSPG-YR2016-JAN-15
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